Drug Interaction Study of Azithromycin and Theophylline

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-07-31

Brief Summary

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Macrolides are potent inhibitors of cytochrome P450 isoenzyme 3A4（CYP3A4）and thus interfere with the pharmacokinetics of many other drugs that are metabolised by this enzyme like theophylline.The aim of this study is to determine whether azithromycin can effect theophylline metabolism in patients.

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Detailed Description

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In this non-blinded,auto-control study,patients with Chronic Obstructive Pulmonary Disease（COPD）or asthma will serve as their own controls during the 2-week treatment phase.The subjects will be co-administered oral doses of sustained release theophylline (100mg tablets,twice daily) and azithromycin (2x250mg capsules,once daily )in the first week.Then patients will received theophylline therapy alone with the same dose in the second week.Blood samples for the measurement of theophylline plasma concentrations will be collected on Days 8 and 15 prior to dosing.All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Conditions

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Chronic Obstructive Pulmonary Disease Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Theophylline with azithromycin

steady-state plasma concentration of theophylline in the presence of azithromycin

Group Type EXPERIMENTAL

Theophylline with azithromycin

Intervention Type DRUG

Drug: Theophylline(100mg,sustained release tablets). Multi-dose of theophylline(100mg,twice daily) will administered at 8 am and 8 pm from day 1 to day 7.

Drug:Azithromycin(250mg, capsules). Multi-dose of azithromycin(500mg,once daily) will administered at 8 pm from day 1 to day 7.

Theophylline alone

steady-state plasma concentration of theophylline alone

Group Type ACTIVE_COMPARATOR

Theophylline alone

Intervention Type DRUG

Drug: Theophylline(100mg,sustained release tablet). Multi-dose of theophylline(100mg,twice daily) will administered at 8 am and 8 pm from day 8 to day 14.

Interventions

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Theophylline with azithromycin

Drug: Theophylline(100mg,sustained release tablets). Multi-dose of theophylline(100mg,twice daily) will administered at 8 am and 8 pm from day 1 to day 7.

Drug:Azithromycin(250mg, capsules). Multi-dose of azithromycin(500mg,once daily) will administered at 8 pm from day 1 to day 7.

Intervention Type DRUG

Theophylline alone

Drug: Theophylline(100mg,sustained release tablet). Multi-dose of theophylline(100mg,twice daily) will administered at 8 am and 8 pm from day 8 to day 14.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with COPD or asthma，aged 18-75 years;
* regularly visiting our hospital;
* meeting the indications for azithromycin and theophylline simultaneously;

Exclusion Criteria

* patients with renal or hepatic dysfunction;
* patients with congestive heart failure;
* patients with hypothyroidism or hyperthyroidism;
* patients taking drugs likely to affect the theophylline metabolism in the preceding week;
* patients with severe chronic obstructive pulmonary disease,asthma or respiratory infection;

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No